Model: STAINBUSTER 2501
Catalog: CPSB0001
DI: B868CPSB00011
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Abrasive Point
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
88001279-c38b-43c4-8526-d96305e81cd8
Distribution Status:
In Commercial Distribution
DUNS Number:
054028295
Device Count:
6
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
B868CPSB00010
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
B868CPSB00011
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 58073
Name: Polymeric dental bur
Definition:
A rotary device intended to be attached to a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming healthy zones of dentin. It is made of glass-bead-reinforced polymer or polyetheretherketone (PEEK) designed to deform on encountering harder, healthy dentin. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.
FDA Product Codes
EHL
POINT, ABRASIVE